MAUDE Adverse Event Report: NAVISWISS AG NAVISWISS HIP NAVIGATION SYSTEM

Device Problem Device Reprocessing Problem (1091)

Patient Problem Unspecified Infection (1930)

Event Date 10/24/2022

Event Type  Injury  

Event Description

A surgeon performed a review of his most recent 118 total hip arthroplasty (tha) cases that involved the use of the naviswiss technology.This review was triggered by the incidence of 3 out of 118 cases presenting with post-operative infection that required ongoing management.The single incidents occured in (b)(6) 2022 and were not reported as single incidents to naviswiss.In march 2023 naviswiss was informed regarding the situation.No allegation was made against the medical device, furthermore the surgeon located the root cause in the in-house reprocessing process (non-compliance).See also section b7.Naviswiss considered this case as not reportable, as the device, according to the surgeon, was not the cause of the infections.During an audit this case was reviewed and considered as reportable.This caused a delay in reporting.

Manufacturer Narrative

After a thorough review of the equipment and procedural aspects at the hospital and given the isolated and clustered occurrence of these infections, it is surgeons opinion that these infections were unrelated to the naviswiss technology.Rather, it appears to be a result of basic procedural issues within the re-processing department, which have now been rectified through additional training measures.These training measures were carried out on april 19th, 2023 and included a thorough review of basic hygienic processes and the well described naviswiss re-processing instructions.Following this initiative, the issue has not recurred.Again, it is surgeon opinion that these 3x cases of post-operative infection were unrelated to the naviswiss platform.Product was not returned for investigation.

• Brand Name: NAVISWISS HIP NAVIGATION SYSTEM
• Type of Device: NAVISWISS HIP NAVIGATION SYSTEM
• Manufacturer (Section D): NAVISWISS AG; stahlrain 2; brugg, ch 5200 ; SZ 5200
• Manufacturer (Section G): NAVISWISS AG; stahlrain 2; brugg, ch 5200 ; SZ 5200
• Manufacturer Contact: domenico romeo ; stahlrain 2; brugg, ch 5200 ; SZ 5200
• MDR Report Key: 18120035
• MDR Text Key: 328000922
• Report Number: 3017123055-2023-00001
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other